René Schade
Director Epidemiology (Global) Qcsr Strategic Development (Portfolio Development) @CSL
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WORK HISTORY
Director Epidemiology (Global) Qcsr Strategic Development (Portfolio Development) @CSL
DE
Global Epidemiology & RWD/RWE Product Lead (Haematology, Gene Therapy, Cardiovascular & Renal, IG), CSL Behring & Vifor- Hemgenix (world\'s first gene therapy for hemophilia B, approved Nov 2022 by FDA & Feb 2023 by EMA)- Post-COVID Hizentra immunoglobulin indication extension (directly to Clazakizumab (CVD in kidney disease; phase 2b/3)- Kcentra/ Beriplex (PCC)- Label extension in hematologic disorders (RWE/RWD applications)- RWD for machine learning/AI: Developmet of prediction tool for trial enrichment/ design- Apolipoportein A-I (recurrent MI/MACE; CSL\'s largest trial to date, AEGIS-II, topline Q1 2024)- aRMM effectiveness evaluation survey (8+ countries)From early development to post-marketing commitments:Ensuring RWE/RWD centricity and optimal RWD usage across CSL. Integrated Evidence Generation. Vendor management. Influencing strategic discussions. Advising on & realizing RWE/RWD applications to align with strategic objectives.Leading RWE, safety epidemiology and benefit-risk assessment. Project Lead for regulatory-required PASS. Chair of global Benefit-Risk Assessment Team, ensuring up-to-standard, structured BRA. Standing member of global Clinical Development Teams and global Safety Mangement Teams, and global Product Strategy Teams.Authoring & reviewing of regulatory documents (eg, Briefing Book, TPP, Clinical Development Plan, Investigational New Drug Application, Risk Management Plan, PBRER/PSUR), study protocols, SAPs etc.
EDUCATION
Humboldt University of Berlin
Master's degree
UCL
Clinical Neurology Internship & Neuroscience Training
McGill University
Epidemiology and Biostatistics (Master's)
Erasmus University Rotterdam
Master's degree
Albertus-Magnus-Gymnasium Dülken
Abitur (university entrance diploma)
ABOUT RENÉ SCHADE
MD, MSc Epidemiology with 19+ Postgraduate Years in Real-World Evidence | Pharmacoepidemiology | Comparative Effectiveness & Safety | Regulatory/HTA Impact | Medical Informatics (RWD)| Big-Data Epidemiology & Advanced Analytics | Global RWD Landscaping/Mapping | Training & Coaching Effective and agile leader, communicator, and team player. Competent in making innovative solutions a reality, including scale-up. Brings out the best in people and multi-disciplinary project teams. Strategist and systems thinker with strong business acumen. Generalist with wealth of experience in oncology, haematology, immunology, neurology and cardiovascular. 14+ Years in highly collaborative, multi-country RWE projects, including the following federated RWD networks- HONEUR Haematological Outcomes Network in Europe (Janssen, J&J)- CVD-REAL study across 6 countries (AstraZeneca, SGLT2i)- SOS Project (5 countries, 7 databases, 35 million patients) 1500+ Citations (2200+ Google Scholar) of original research articles, mainly longitudinal RWE studies of comparative effectiveness/safety (high risk). Publications/slides: 25+ Years in clinical medicine and/or health sciences. First pharmaceutical job 23+ years ago in Global Pharmacovigilance. Interested in- Team building & people development - Strategy, business development, process improvement - Integrated value/evidence/access strategies - External (real world) control arms & Bias analysis - PASS/PAES - Federated data networks (FDNs), common data models - Precision medicine - Data science, NLP, predictive analytics/ machine learning Extensive experience in design & delivery of RWE with top-tier healthcare databases (mainly as Project Lead): Gained traction 19+ years ago as Principal Investigator who made innovative use of UK\'s CPRD. More recently, worked with the likes of JMDC (Japan), MDV (Japan), Flatiron (US), Optum (US), Diabetes Collab. Registry (US), GePaRD (Germany), Lombardy Regional Database (Italy), NCRAS (UK), THIN (UK), Hospital Episode Stats (UK), IPCI (NL), PHARMO (NL), and Nordic registries (Scandinavia). Advanced: SAS and SQL. Basic: R and Python Fluent in English, Dutch, German (native), and Spanish. Please don\'t hesitate to write me a message. For specific responsibilities in current and past roles, please see texts in Experience sections and publications below. Endorsements/recommendations have always been disabled for this profile
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